Clinical Research Data Coordinator II- Winship Cancer Institute

About the role

The Data Coordinator II supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. They facilitate initial visits with study subjects, design, build, and maintain the database, analyze subject data, and manage complex projects related to data acquisition and tracking.

Responsibilities

• Primary Data Coordinator for complex interventional therapeutic clinical trials, including multi-center trials and WCI held Investigator Initiated Trials (IITs).
• Independently responsible for all aspects of clinical data management including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
• Reviews and analyzes information from medical records to extract data for all assigned research protocols.
• Accurately captures and enters data into clinical trial databases as necessary, and within timelines set by study sponsors or CTO.
• Collects and maintains complete records and metrics on each research study participant.
• Consolidates clinical data and reports for investigators as needed.
• Assists in the review and evaluation of potential research studies and communicates effectively with CTO management and leadership regarding feasibility of proposed projects.
• Attends study team meetings and provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and query management.
• Supports Data Team Supervisor in onboarding, training, and quality assurance of DC I position.
• Serves as a resource to provide support and guidance to less experienced DCs and other study team members.
• Liaises with sponsors and the in-house monitoring team, schedules monitoring visits, and addresses monitoring report findings.
• Leads the DC effort in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data.
• Serves as the lead DC in preparing for internal and external audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective action plans post audit.
• Establishes and maintains procedures and systems (i.e., computerized database) for research coordination and data management.
• Provides support to Winship’s Informatics team as they develop and improve research information systems.
• Serves as a resource to provide support and guidance to less experienced DCs and other study team members.
• Attends protocol related training meetings and completes all required study training.
• Serves as the lead DC in preparing for internal and external audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective action plans post audit.

Requirements

• Bachelor Degree and at least two (2) years of clinical research data management experience OR High School Diploma or GED and at least six (6) years of clinical research data management experience OR an equivalent combination of education and experience.
• Prioritizes and meets deadlines.
• Strong attention to detail and ability to work independently.
• Excellent interpersonal skills and ability to communicate effectively with various stakeholders.
• Proficient in Microsoft Office Suite, including Excel and Access.
• Experience with electronic data capture (EDC) systems.
• Knowledge of HIPAA regulations and confidentiality standards.

Qualifications

• Bachelor Degree and at least two (2) years of clinical research data management experience OR High School Diploma or GED and at least six (6) years of clinical research data management experience OR an equivalent combination of education and experience.
• Prioritizes and meets deadlines.
• Strong attention to detail and ability to work independently.
• Excellent interpersonal skills and ability to communicate effectively with various stakeholders.
• Proficient in Microsoft Office Suite, including Excel and Access.
• Experience with electronic data capture (EDC) systems.
• Knowledge of HIPAA regulations and confidentiality standards.

Skills

• Strong organizational and problem-solving skills.
• Ability to prioritize and meet deadlines.
• Excellent communication and interpersonal skills.
• Proficiency in Microsoft Office Suite, including Excel and Access.
• Experience with electronic data capture (EDC) systems.
• Knowledge of HIPAA regulations and confidentiality standards.

Benefits

• Comprehensive health insurance coverage.
• Retirement savings plan with employer match.
• Flexible work schedule.
• Professional development opportunities.
• Employee assistance program.

Pay

Competitive salary commensurate with experience.

Schedule

Full-time, Monday through Friday, 8:00 AM to 5:00 PM.